A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants

NCT07535970 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10506-113
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.

Conditions

Healthy Participants

Keywords

Phase 1; Drug interaction; Itraconazole; HS-10506; Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Evaluation of PK parameters of HS-10506: Cmax

  To evaluate the Cmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: AUC0-t

  To evaluate the AUC0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: AUC0-∞

  To evaluate the AUC0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.

  120 hours after administration of HS-10506

Secondary Outcomes (19)

• Evaluation of PK parameters of HS-10506:Tmax

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: t1/2z

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: λz

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: CL/F

  120 hours after administration of HS-10506

• Evaluation of PK parameters of HS-10506: Vz/F

  120 hours after administration of HS-10506

Study Arms (1)

Experimental group

EXPERIMENTAL

Drug-drug interaction Arm

Drug: HS-10506, Itraconazole

Interventions

HS-10506, Itraconazole DRUG

HS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days.

Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;
• Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);
• Participant's Body Mass Index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;
• Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the trial).

You may not qualify if:

• Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;
• Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;
• lead electrocardiogram results during the screening period showing QTcF\>450.00 ms for males or QTcF\>470.00 ms for females;
• Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;
• Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;
• Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.);
• Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF;
• History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment;
• Participation in any other clinical trial involving any investigational drug or device within 3 months before screening, or within 7 half-lives of another investigational drug before screening, whichever is longer;
• Prone to allergic reactions, or allergic constitution(e.g., allergies to pollen, two or more drugs/foods), or known allergy to components of HS-10506 tablets or itraconazole capsules;
• History of drug abuse, drug dependence, or use of illicit drugs within 5 years before screening, or positive drug abuse screening results;
• Frequent alcohol consumption within 3 months before screening (i.e., consuming more than 14 units of alcohol per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine, equivalent to 10 bottles of beer, 500 mL spirits, or 3 bottles of wine per week), or inability to stop consuming alcoholic products during the trial, or positive alcohol breath test;
• Average daily smoking of more than 5 cigarettes within 3 months before screening, or inability to stop using any tobacco products during the trial;
• Excessive consumption of tea, coffee, and/or caffeinated beverages within 3 months before screening (average of more than 8 cups per day; 1 cup = 200 mL);
• Significant blood loss(≥200 mL)or blood donation within 3 months before screening, or plans for blood donation during the study or within 3 months after the study;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Wei Zhao, Doctor

CONTACT

0531-82169023; zhao4wei2@hotmail.com

Wen Shu Yu, Doctor

CONTACT

0531-82169023; yaoxuebu2012@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 17, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-02

Locations

CN (1)